Umbrella device (occluder) with modified coating layer

FIELD: medicine.

SUBSTANCE: what is described is an umbrella device (occluder) with a modified coating layer for the left atrial appendage occlusion. The umbrella device (occluder) with the modified coating layer is made from a titanium nickelide alloy. It has the coating modified layer having a thickness of 80-95 nm which consists of at least two sub-layers: an external sub-layer having a thickness of 20-25 nm contains oxygen, carbon, silicone and titanium in the following ratio, at %: oxygen 25-65, carbon 1-5, silicone 1-10, titanium - the rest; an intermediate sub-layer having a thickness of 60-70 nm contains oxygen, carbon, silicone, titanium and nickel in the following ratio, at %: oxygen 5-30, carbon 1-5, silicone 10-30, nickel 1-50, titanium - the rest, with silicone reaching its maximum concentration at a depth of 30-35 nm from the surface. The modified coating layer of the umbrella device (occluder) has no evident interface of the sub-layers specific for a deposited layer.

EFFECT: umbrella device with the modified coating layer possesses biocompatibility, corrosive resistance and no toxicity.

9 cl, 2 dwg

 

The invention relates to the manufacture of cardioselective, mainly the umbrella of devices, from an alloy based on Nickel-titanium shape memory effect (APF) and sverkhelastichnosti with modified ion-plasma treatment of the surface layer intended for continuous use in the cardiovascular system of the body and having corrosion resistance, biocompatibility and toxicity in biological environments.

The known device represented by the Corporation AGA Medical Corparation (USA) and disclosed in U.S. patents, such as US 5725552 (published 10.03.1998)US 5846261 (published 08.12.1998)US 5944738 (published 31.08.1999)US 6123715 (published 26.09.2000). Devices made from braiding metal mesh formed by weaving the wire elements from possessing shape memory Nickel-titanium alloy (often called nitinol - Nitinol). These devices are highly specialized and are well suited for the selective occlusion of a vessel, lumen, channel, hole, cavity or the like, such as atrial septal defects, open oval window, patent ductus arteriosus, ventricular septal defect, and arterial venous fistula.

It is known from patent US 6652556 (published 25.10.2003) a filter device for left atrial appendage (SFM which has a frame made of wire elements are made of Nickel-titanium alloy.

It is known from the publication US 2003/0023266 (published 30.01.2003) implanted in the left atrial appendage device from an alloy with shape memory, executed in full accordance with the individual anatomical characteristics of size, shape and the inner surface of the left atrial appendage of a patient.

A common disadvantage to all of the above variants of this device is that they do not have a modified surface layer.

Known dental intraosseous implant material with shape memory effect for its production (EN 2397732, AS 8/00, SS 19/03, publ. 27.08.2010). The design intraosseous dental implant. The material for the manufacture of the implant consists of a base and a surface layer, modified alloying elements: oxygen, carbon by ion implantation. The surface layer has a thickness of between 100 to 700 nm, and as an alloying element further comprises molybdenum, the following relation of elements, at.%: oxygen - 20-70; carbon - 5-10; molybdenum - 15-30; titanium - 5-35; Nickel - 0-10. The technical result - increasing the mechanical stability of the implant during installation through hole viewduring tooth and its corrosion resistance and biocompatibility through which create a barrier for ion-modified layer on its surface.

The disadvantage of the invention is that the claimed dental intraosseous implant the invention relates to dentistry.

Known medical designs, in particular, cardiomypathy from a material with shape memory, such as an alloy based on titanium nickelide (US 2006157159, A61L 27/06, A61L 27/50, SS 14/48, SS 8/36, publ. 2006.07.20), with modified surface layer, using the methods of ion-beam or plasma immersion implantation or deposition of ions to modify the surface properties of these materials. Surfaces treated with nitrogen, oxygen and carbon, becomes biologically inert.

The lack of health structures, in particular, cardiospectra with surface modified by ion implantation alloying elements mentioned in the famous invention is the fact that known modified surface layer is not possible to isolate the biological media from the products of dissolution of components of the structure material, in particular Nickel, and does not provide a quick integration of cardiospectra with animal or human body.

Also known in the invention noted as a recommendation that the silicon can be used to create a bioinert surface cardiospectra. However, in the known invention is not declared chemical with the becoming of the surface layer of cardiospectra, including the content of atoms of Nickel and its change associated with a change in the content of atoms of silicon and other alloying elements.

Object of the present invention to provide an umbrella device (occluder) with modified surface layer for occlusion of the left atrial appendage. The proposed umbrella device with modified surface layer has biocompatibility, corrosion resistance and non-toxicity.

This technical result is achieved by the fact that the umbrella device (occluder) with modified surface layer is made from an alloy based on titanium nickelide, it has a surface modified layer thickness of 80-95 nm, which consists of at least two sublayers:

the outer sublayer thickness of 20-25 nm contains oxygen, carbon, silicon and titanium in the following ratio of the elements, at.%:

oxygen25-65
carbon1-5
silicon1-10
titaniumrest

intermediate sublayer thickness of 60-70 nm contains oxygen, carbon, silicon, titanium and n is Kel in the following ratio of the elements, at.%:

oxygen5-30
carbon1-5
silicon10-30
Nickel1-50
titaniumrest

moreover, the maximum concentration of the silicon reaches at a depth of 30-35 nm from the surface.

The umbrella device (occluder) is made of double-base alloy Nickel-titanium, having the following chemical element composition, at.%:

titanium49.00-49.50
Nickel50.50-51.00

The umbrella device (occluder) is made of dual alloy based on titanium nickelide, with additional impurity introduction of O, N, and substitution of Fe, Co to 0.2 at.%.

In addition, dual alloy based on titanium nickelide has a temperature of completion of the reverse martensite transformation, when it is heat, not more than 23°C and the magnitude of the reversible inelastic deformation of not less than 6%.

The modified surface layer of the umbrella device (occluder) is produced by processing it is poverhnosti flows silicon ions at an accelerating voltage of 40 to 80 kV, when the pulse frequency of 50-100 Hz for 5-60 minutes, in the mode of high-dose ion implantation.

Before processing the surface of the umbrella device (occluder) flows silicon ions carry out chemical and electrochemical cleaning of its surface.

Chemical cleaning of the surface of the umbrella device (occluder) is carried out in a mixture of nitric and hydrofluoric acid at a temperature of 50°C.

Electrochemical surface cleaning device umbrella (occluder) is carried out in the mixture of acids CH3COOH (97%): HClO4(70%)taken in the ratio 3:1 obj

The use of an alloy based on titanium nickelide, in particular, in the range of the following composition, at.%:

titanium49.00-49.50
Nickel50.50-51.00

in cardiovascular surgery as a material for cardiovention, mainly the umbrella device (occluder), associated with the presence of this alloy valuable mechanical properties, such as thermal shape memory, sverkhelastichnosti. In particular, the aforementioned dual alloy based on titanium nickelide may have additional impurity introduction of O, N, and substitution of Fe, Co to 0.2 at.%. The content of such a small number of said p is imesa no significant impact on its functional properties. Mentioned dual alloy based on titanium nickelide has a temperature of completion of the reverse martensite transformation (AK), when it is heat, not more than 23°C and the magnitude of the reversible inelastic deformation of not less than 6%.

The specified properties of the dual alloy based on titanium nickelide required to perform the umbrella device (occluder) certain structures that require restore its shape when the temperature of the human body, as well as for his long work in the organs of the cardiovascular system under load (muscular pressure on the structure side walls of blood vessels).

The presence of a significant proportion of the atoms of Nickel in the alloy (50.50-51.00 at.%) necessitates the creation of the barrier layer prevents the penetration of Nickel ions in biological media (tissue and fluids - blood, lymph, blood) as a result of corrosion processes occurring on the surface of the umbrella device (occluder) from an alloy based on titanium nickelide in contact with biological tissues and fluids and is accompanied by release of Nickel ions. The increase in the atomic concentration of Nickel in the tissues above the permissible level contributes to the deterioration of the biological compatibility of the umbrella device (occluder), has on the body of toxic and allergic effects, can cause will nosplit the selected processes.

The present invention, an apparatus umbrella (occluder) from an alloy based on titanium nickelide with modified surface layer.

The modified surface layer of the umbrella device (occluder) thickness 80-95 nm comprises at least two sublayers:

the outer sublayer thickness of 20-25 nm contains oxygen, carbon, silicon and titanium in the following ratio of the elements, at.%: oxygen 25-65, 1-5 carbon, silicon 1-10, titanium rest;

intermediate sublayer thickness of 60-70 nm contains oxygen, carbon, silicon, titanium and Nickel in the following ratio of the elements, at.%: oxygen 5-30, 1-5 carbon, silicon 10-30, Nickel 1-50, titanium else, and the maximum concentration of the silicon reaches at a depth of 30-35 nm from the surface.

The choice of silicon as the main chemical element for doping the surface of the umbrella device (occluder) from an alloy based on titanium nickelide will allow you to solve some of these problems due to its chemical (electronic analogue of carbon), physical (partially dissolved in the lattice of titanium with the formation of a limited solid solution substitution and forms biologically inert, insoluble phase on the basis of titanium, Nickel and silicon, which may be the basis for the synthesis of composite metal-ceramics based on titanium and silicon) and biological is practical (high compatibility with living cells) properties.

Figure 1 shows the proles of concentration of the main elements in the surface layers of the alloy TiNi before (a) and after ion modification of silicon (b).

From declared concentration distribution of chemical elements in the surface layer of the umbrella device (occluder) from an alloy based on titanium nickelide seen a significant decrease in the Nickel content in the outer layer of a thickness of from 20 to 35 nm, compared with its content in the internal volume, until the complete absence of Ni atoms on the surface of the device, an umbrella, and under it, in a depth of 20 nm from the surface. The modified surface layer thickness 80-95 nm, comprising at least two sublayers, varies considerably with the concentration ratio of oxygen, carbon, Nickel and silicon, and has no pronounced surface section between the sublayers characteristic of the deposited layer.

Figure 1(b) presents the concentration profiles of major chemical elements in the surface layer of the umbrella device (occluder) from an alloy based on titanium nickelide. It is seen that the maximum surface concentration of oxygen and carbon, 50 at.% and 20 at.%, accordingly, decreases exponentially in a rather narrow outer layer and at a depth of 10-20 nm is less than 5 at.%, each. Distribution in edrnnih ions of silicon describes a curve with a maximum concentration of silicon 30 at.%, located in the surface region, as it was mentioned above, at a depth of 30-35 nm from the surface.

The presence of carbon in the modified surface layer caused by the existence of adsorbed carbon on the original surface of the umbrella device (occluder), on the surface of the sprayed material (the cathode of the silicon), and the presence of residual carbon in the atmosphere technical vacuum, which (carbon) on the mechanisms of atomic mixing and diffusion penetrates into the deeper layers of the processed alloy based on titanium nickelide.

From figure 1(b), it follows that the oxygen concentration in the modified surface layer is increased, and the thickness of this layer 2 times the thickness of the oxide layer of the umbrella device (occluder) to the ion processing. This is because in the process of ion implantation in addition to atoms of the main implantable chemical element (silicon), as a rule, in the ion beam are such elements as oxygen is present, as in the residual atmosphere of the working chamber and adsorbed on the surface of the irradiated devices umbrella (occluder). In the process of ion processing silicon, due to atomic mixing of surface and internal layers, and radiation-enhanced diffusion, ions of this element p. the fall in the surface layer and are distributed in it, by participating in the formation of the modified surface layer.

Particularly noteworthy features of the redistribution of Ni atoms in the surface modified layer.

From figure 1(b) shows that the external (outer) sublayer thickness of 20 nm, the Ni atoms are practically absent, then the increase of their concentration to a value corresponding to its initial concentration in the alloy at a depth of 80-95 nm from the irradiated surface.

From the results of the corrosion tests, it follows that the potential of prepassivate EPPalloy based on titanium nickelide in biochemical aqueous 0.9% NaCl, blood plasma after modifying the surface of the umbrella device (occluder) average of 0.9 In, unlike its values EPP≈0.8, obtained when testing devices umbrella (occluder) with unmodified surface. Improving the corrosion resistance of the surface of the umbrella device (occluder) from an alloy based on Nickel-titanium ions with modified silicon surface layer due to the declared chemical composition of the elements in the surface layer of the umbrella device (occluder). Its modified surface formed of at least two highly corrosion-resistant bioreactors sublayer, one positioned above the other: first - outer-based oxy-carbides titanium sublayer based on titanium, oxygen and carbon) and the second intermediate oxide of silicon, silicides of titanium and Nickel. In the potentiostatic exposure in biochemical solutions when the value of the anode potential E is greater than the value of fixed potential Earticlefor alloy based on titanium nickelide, except vysokokorrozivnuyu-resistant compounds based on titanium, such as T2Si, Ti5Si3possibly the formation of poorly soluble compounds Ni2SiO4that may be one reason for the stabilization of the passive state of the surface layer of the umbrella device (occluder) in the field of positive potentials to enhance its corrosion resistance.

Tests results from in vitro biocompatibility with living cells were used mesenchymal stem cells (MSC) from bone marrow of rats) umbrella device (occluder) from an alloy based on titanium nickelide with unmodified and modified (silicon) surface layer obtained that the efficiency of cell proliferation of MSC on the surface of the umbrella device (occluder) after ion modification was ~1.3 times higher than on the surface of the umbrella device (occluder), which are not subjected to the ion processing silicon. This means that after modification by ion beams silicon biocomercio the te device umbrella (occluder) increased.

The present invention is as follows.

From the tube dual alloy based on titanium nickelide diameter of 3 mm using a laser cutting apparatus (disk laser with diode pumping) specially given program in the walls of the tube cut out the holes and cuts the desired geometry for receiving the frame of the workpiece.

Carry out chemical cleaning frame piece, which is required to remove defects of the laser cutting type flows, splashes and reduce the thickness of the oxide film. For this frame, the workpiece is treated with a mixture of nitric and hydrofluoric acid at a temperature of 50°C for 5-7 seconds. Spend the sink frame workpiece in an ultrasonic bath in distilled water.

Next frame the workpiece with a forming templates give the required three-dimensional shape of the umbrella device (occluder). For this pre-cooled frame billet pull on the cooled inner forming the template and clamp cooled forming the template. This operation is carried out at temperatures from minus 15 to plus 5°C. Gripped the workpiece by the forming templates are placed in a molten mixture of inorganic salts at a temperature of 450-475°C for 15 minutes. Spend the quenching of the workpiece in water at room temperature, and then surround the workpiece device sonicing the (occluder) free from external template and removed from the internal template (see figure 2(a)).

Further, the umbrella device (occluder) is subjected to electrochemical cleaning in a mixture of CH3COOH (97%): HClO4(70%)taken in the ratio 3:1 OBC, when the electrolyte temperature is 0°C, the processing time is 10-15 seconds at a voltage of 30 C. After electrochemical cleaning device umbrella (occluder) washed in distilled water in an ultrasonic bath. Washed umbrella device (occluder) is subjected to drying.

Next, perform a surface treatment device of the umbrella (occluder) accelerated ions of silicon in vacuum ion-plasma installation (later in the installation).

For this to be processed similar umbrella device (Amplatzer) are secured in holders positioning system desktop installation. The positioning system provides uniform processing of external and internal surfaces of several (up to 10 pieces) devices umbrella (occluders) the flow of ions of silicon. Desk moved into the working chamber. The chamber is pumped out to a pressure of not less than 3·10-3PA (2·10-5Torr) to reduce the content of impurity atoms (oxygen, carbon) in the residual atmosphere to the minimum of their concentration.

Include a system of heating-cooling of the working chamber. Luggage must be warmed up to a temperature of 30-35°C. Install speeds up the total voltage of 60 kV, a bias voltage of 1000 V, a pulse frequency of 50 Hz, include pulsed ion accelerator silicon and positioning system. Ion surface modification device umbrella (occluder) is carried out with the use of pulsed single-component ion beams of silicon under conditions of oil-free pumping and high vacuum mode high-dose ion implantation with a fluence of 2×10 cm-2. In the process provide rotation of each device umbrella (occluder) along a given trajectory to achieve a uniform distribution of radiation dose on the surface of the processed devices umbrella (occluder). For unloading the processed umbrella device (occluder) in the camera setup putting the air, roll the table and take out the processed umbrella device (Amplatzer). Described ion processing silicon provides the thickness of the modified surface layer 80-95 nm and declared the chemical composition of the elements within the modified surface layer of the umbrella device (occluder) (see figure 2(b))required to achieve the stated technical result.

1. The umbrella device (occluder) with modified surface layer made from an alloy based on titanium nickelide, characterized in that it has a surface modified by the initial layer thickness of 80-95 nm, comprising at least two sublayers:
the outer sublayer thickness of 20-25 nm contains oxygen, carbon, silicon and titanium in the following ratio of the elements, at.%:

oxygen25-65
carbon1-5
silicon1-10
titaniumrest

intermediate sublayer thickness of 60-70 nm contains oxygen, carbon, silicon, titanium and Nickel in the following ratio of the elements, at.%:
oxygen5-30
carbon1-5
silicon10-30
Nickel1-50
titaniumrest

moreover, the maximum concentration of the silicon reaches at a depth of 30-35 nm from the surface.

2. The device according to claim 1, characterized in that it is made of double-base alloy Nickel-titanium, having the following chemical element composition, at.%:

titanium49.00-49.50
Nickel50.50-51.00

3. The device according to claim 2, characterized in that it is made of dual alloy based on titanium nickelide, with additional impurity introduction of O, N, and substitution of Fe, Co and 0.2 at.%.

4. Device according to any one of claim 2 or 3, characterized in that the dual alloy based on titanium nickelide has a temperature of completion of the reverse martensite transformation, when it is heating, not about 23°C.

5. Device according to any one of claim 2 or 3, characterized in that the dual alloy based on titanium nickelide has a value reversible inelastic deformation of not less than 6%.

6. The device according to claim 1, characterized in that the modified surface layer is produced by processing the surface flows silicon ions at an accelerating voltage of 40 to 80 kV, at a pulse frequency of 50-100 Hz for 5-60 minutes, in the mode of high-dose ion implantation.

7. The device according to claim 6, characterized in that before processing the surface flows of ions of silicon carry out chemical and electrochemical treatment.

8. The device according to claim 7, characterized in that the chemical cleaning of the surface is carried out in a mixture of nitric and hydrofluoric acid at a temperature of 50°C.

9. The device according to claim 7, characterized in, Thu the electrochemical cleaning of the surface is carried out in the mixture of acids CH 3COOH (97%):HClO4(70%)taken in the ratio 3:1 OBC



 

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16 cl, 8 dwg

FIELD: medicine.

SUBSTANCE: group of inventions refers to surgery and may be used for making external osteosynthesis implants. An osteosynthesis system comprises a piece part on an external surface of which there is a layer of a polymer film in the electret state with the layer of the polymer film made of a fusible element. The group of inventions refers to a method for making the osteosynthesis system involving preparation the layer of the polymer film on an external surface of the piece part by coating the surface of the piece system with a fine fusible polymer powder, fusion thereof on the surface of the piece part and electrostatic charging of the prepared film.

EFFECT: group of invention provides making a uniform coating of the electret layer on the surface of the piece part of the osteosynthesis system firmly attached to the surface of the piece part that enables faster fusion of bone fragments due to electric stimulation and prevented implant corrosion.

10 cl, 1 ex

FIELD: medicine.

SUBSTANCE: described are soft, having high index of refraction acrylic materials for devices. Materials include di-block or tri-block macromers, containing hydrophilic side chains.

EFFECT: materials have improved stability to reflections.

17 cl, 6 tbl, 12 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine. There are described soft acrylic materials having a high refraction coefficient for apparatuses. The materials contain diblock- or triblock-marcomers containing a hydrophilic block in a polymer backbone.

EFFECT: materials have better gloss resistance.

17 cl, 3 tbl, 7 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described are soft acryl materials for ophthalmologic or otorhinolaryngologic devices, which have high refraction coefficient.

EFFECT: materials contain macromer with hydrophilic side chain for giving stability to appearance of glitter.

20 cl, 6 tbl, 1 ex

FIELD: medicine.

SUBSTANCE: what is described is a method for making endosseous implants involving a plasma lamination of a biologically active coating on a metal base of the implant; titanium is sprayed remotely as the first and second layer, while the third layer is a mechanical mixture of titanium and hydroxyapatite powders; the fourth layer is formed on the basis of hydroxyapatite or aluminium oxide by mixing a boehmite powder of dispersity no more than 50 nm with hydroxyapatite or aluminium oxide powders in the amount of 5-20% of the boehmite powder of total substances; boehmite is taken in the form a suspension prepared by adding a surfactant dissolved in distilled water in the concentration of 0.25-5%, treated in an ultrasonic bath; then, the prepared suspension of boehmite and hydroxyapatite or aluminium oxide is treated in the ultrasonic bath, dried, tempered and milled.

EFFECT: endosseous implants have the high-strength biocompatible coating.

5 cl, 2 dwg

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